21 U.S.C. § 360n–1 — Priority review for qualified infectious disease products

submitted 88 years ago by Pub. L. 112-144 to r/title-21-FOOD-AND-DRUGS · 108 words · no verdicts yet

in plain englishAI-generated · not legal advice

If the FDA calls a drug a 'qualified infectious disease product,' it gets priority review. This applies to the first approval application with clinical data proving safety or effectiveness. The FDA can still give priority review to other qualifying applications too.

(a) In general If the FDA designates a drug under section 355f(d) as a "qualified infectious disease product," then the FDA must give priority review to the first application submitted to approve that drug — filed under section 355(b) or section 262(a) of title 42 — as long as that application includes clinical data (not just bioavailability studies) needed to show the drug is safe or effective. (b) Construction This section doesn't stop the FDA from also giving priority review to any other human drug application or efficacy supplement that separately qualifies for priority review under the normal rules.

the actual law source: uscode.house.gov ↗public domain

(a) In general

If the Secretary designates a drug under section 355f(d) of this title as a qualified infectious disease product, then the Secretary shall give priority review to the first application submitted for approval for such drug under section 355(b) of this title, or section 262(a) of title 42, that requires clinical data (other than bioavailability studies) to demonstrate safety or effectiveness.

(b) Construction

Nothing in this section shall prohibit the Secretary from giving priority review to a human drug application or efficacy supplement submitted for approval under section 355(b) of this title that otherwise meets the criteria for the Secretary to grant priority review.

Source credit: (June 25, 1938, ch. 675, § 524A, as added Pub. L. 112–144, title VIII, § 802(a), July 9, 2012, 126 Stat. 1079; amended Pub. L. 114–255, div. A, title III, § 3101(a)(2)(N), Dec. 13, 2016, 130 Stat. 1154; Pub. L. 117–328, div. FF, title III, § 3212(b), Dec. 29, 2022, 136 Stat. 5826.)

history & why it existsrecord from the source credit

1938Enacted · Pub. L. 112-144 · 126 Stat. 1079
2016Amended · Pub. L. 114-255 · 130 Stat. 1154
2022Amended · Pub. L. 117-328 · 136 Stat. 5826

A history note hasn’t been published yet. The record shows enactment by Pub. L. 112-144 on 1938-06-25.

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